GlycoMimetics : Awarded NIH Grant to Study Drug Candidate in Diabetes

August 16, 2009 -- GlycoMimetics, Inc., a clinical-stage biotechnology company that is developing a new class of glycobiology-based therapies for a broad range of indications, announced it has been awarded a grant from The National Heart, Lung, and Blood Institute (NHLBI) of The National Institutes of Health (NIH) to evaluate its E-selectin small molecule antagonists in animal models of vascular complications of diabetes.

The grant is based upon substantial data in the scientific literature suggesting an important role for E-selectin in the chronic inflammation associated with diabetes. The company has developed a family of potent small molecule E-selectin antagonists which it is currently optimizing for oral availability... GlycoMimetics' Press Release -

EXSULIN : PUBLICATION OF PHASE 2 TRIAL RESULTS FOR NOVEL ISLET REGENERATION TREATMENT IN TYPE 1 & TYPE 2 DIABETES

(August 18, 2009) – Exsulin Corporation announced milestones achieved and immediate plans to move forward as a well supported Minnesota-based company dedicated to the development of regeneration therapies for the treatment of diabetes mellitus. Exsulin’s focus is on development of a drug with potential to become a breakthrough therapy for patients suffering from type 1 (T1DM) and type 2 diabetes (T2DM). Phase II human clinical trial data of ExsulinTM (INGAP peptide), a peptide drug product aimed at restoring the ability of the pancreas to produce insulin normally in people with diabetes mellitus, have just been published online by Diabetes/Metabolism Research and Reviews.




Exsulin Corporation, founded by diabetes industry professionals, is supported by a proven clinical, development and regulatory management team and is advised by globally recognized diabetes experts. To follow on and support the results documented in the recent trial data publication, Exsulin has received clearances for a trial in patients with established (not newly diagnosed) T1DM, a population subset with no other currently active clinical trials. Other milestones achieved by Exsulin include reformulation and procurement of drug product, support of key independent laboratory research, and securing regulatory authorization to initiate a new clinical trial... Exsulin's Press Release -

Lexicon : Phase 1 Clinical Trial and Phase 2 Clinical Trial of LX4211 in Patients with Type 2 Diabetes

September 15, 2009 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, obtained favorable results from recently completed Phase 1 studies of LX4211 and announced that it has initiated a Phase 2 clinical trial of the drug candidate in patients with type 2 diabetes mellitus. LX4211 is an orally-delivered, small molecule drug candidate that inhibits the sodium glucose transporter 2 (SGLT2). LX4211 is Lexicon’s fourth drug candidate currently being tested in Phase 2 clinical trials... Lexicon Pharmaceuticals' Press Release -

Intarcia Therapeutics : Enrollment of ITCA 650 Phase 2 Study in Type 2 Diabetes

September 17, 2009 - Intarcia Therapeutics, Inc. announced the start of enrollment for a phase 2 study comparing its proprietary drug candidate ITCA 650 (DUROS continuous delivery of exenatide) with Byetta, an FDA-approved twice-daily injection form of exenatide. Building upon the successful completion of a 28-day phase 1b study of ITCA 650 in May of this year, the phase 2 study is intended to evaluate the doses achieving the best results in the phase 1b in a larger study population and for a longer duration of treatment. In addition, an extension phase of the phase 2 study will evaluate dose response of ITCA 650. Patients receiving Byetta for the first 12 weeks will be switched from Byetta to one of two doses of ITCA 650 to evaluate the potential for improving treatment effect... Intarcia Therapeutics' Press Release -

Medarex : Milestone Payment from FibroGen for the Initiation of a Phase 2 Study of FG-3019 in Patients with Diabetic Kidney Disease

Jul. 13, 2009-- Medarex, Inc. (NASDAQ:MEDX) announced it will receive a milestone payment of an undisclosed amount from its licensing partner, FibroGen,Inc., in connection with a recently initiated Phase 2 clinical trial of FG-3019 in patients with type 2 diabetes and advanced kidney disease as announced by FibroGen on June 15, 2009.



FG-3019 is a fully human monoclonal antibody generated using Medarex's UltiMAb(R) technology against connective tissue growth factor(CTGF). Under the agreement with FibroGen, Medarex could receive future milestone payments and sales-based royalty payments... Medarex's Press Release -

Kineta : Novel Drug Candidates from Airmid for Potential Treatment of Multiple Sclerosis, Type 1 Diabetes and other Autoimmune Diseases

July 7, 2009, – Kineta, Inc. of Seattle and Airmid Incorporated of Redwood City, CA jointly announce an agreement in which a Kineta subsidiary has acquired exclusive commercial rights to a portfolio of novel therapeutic compounds from Airmid. The array of compounds holds extraordinary potential for the treatment of multiple sclerosis, type 1 diabetes mellitus and numerous other autoimmune diseases...

...


Kineta, Inc. is a Seattle-based privately held biotechnology company specializing in clinical advancement of drugs that modulate and enhance the human immune system. Our world class scientists are pioneers, developing life-changing classes of drugs that harness the power of the immune system to fight disease. Kineta seeks to improve the lives of millions of people suffering from autoimmune and viral diseases... [PDF] Kineta's Press Release -

Andromeda Biotech Consummates Deal with Teva for the Commercialization of DiaPep277, its Late Stage Development Drug for Type 1 Diabetes

June 22, 2009 -- Teva completes $13.5 million investment in Andromeda and receives a worldwide exclusive license to commercialize DiaPep277 -- Andromeda Biotech Ltd. , announced that Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) has decided to exercise its option to complete a $13.5 million investment and license Andromeda’s DiaPep277 for the treatment of Type 1 diabetes. Pursuant to the agreements, Teva is receiving worldwide marketing rights for the DiaPep277 product...


... About Andromeda Biotech
Andromeda Biotech Ltd., a subsidiary of Clal Biotechnology Industries Ltd. (TASE: CBI), is focused on the development of an innovative treatment for autoimmune diabetes. Andromeda’s DiaPep277, currently in Phase III Clinical Studies, is a novel therapeutic approach in treating Type 1 diabetes. It is a unique peptide derived from the human protein, HSP60, which immunomodulates the immune system, prevents the destruction of pancreatic cells that secrete insulin and preserves their natural function... Andromeda Biotech's Press Release -

BMS & AstraZeneca : Dapagliflozin Study Demonstrated Improved Glycemic Control In Type 2 Diabetes Patients Treated With High Doses of Insulin...

June 06, 2009 -Results from a 12-week study demonstrated that the investigational drug dapagliflozin, a novel, selective, sodium glucose co-transporter 2 (SGLT2) inhibitor, produced greater improvements across all key glycemic measures studied [glycosylated hemoglobin level (HbA1c), fasting plasma glucose (FPG) and post-prandial glucose (PPG)] in type 2 diabetes patients who were treated with high doses of insulin and commonly used oral anti-diabetes medications (OADs), compared to placebo (placebo plus OADs plus insulin).

Overall adverse events across the dapagliflozin treatment arms were reported at a similar rate to placebo. The study also showed that individuals receiving dapagliflozin had greater reductions in body weight compared to individuals taking placebo, and support the findings from a previous 12-week, Phase 2b study. Results from the 12-week study were presented at the 69^th American Diabetes Association Annual Scientific Sessions.

Dapagliflozin is an investigational SGLT2 inhibitor currently in Phase 3 trials under joint development by Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) as a once-daily therapy for the treatment of type 2 diabetes. SGLT2 facilitates the reabsorption of glucose in the kidney, thereby returning filtered glucose to the circulation.. BMS' Press Releases -

Halozyme : Phase 2 Insulin-PH20 Study Demonstrates Faster Insulin Absorption and Superior Glucose Control in Type 1 Diabetic Patients

Jun. 6, 2009 - Insulin-PH20 combination significantly reduced post-meal blood glucose concentration relative to treatment target resulting in reduced hyperglycemia - Halozyme Therapeutics, Inc. (Nasdaq: HALO) announced Phase 2 results that demonstrated faster insulin absorption and increased peak insulin concentrations in type 1 diabetic patients after co-administration of its recombinant hyaluronidase enzyme (PH20) with Humalog® (insulin lispro), a mealtime insulin analog. Study results also showed a significant reduction in postprandial blood glucose levels following administration of a standardized test meal, with improvements in both peak glycemic response and total hyperglycemic exposure compared to Humalog alone. Mean glucose levels after the meal challenge remained within current treatment targets throughout the eight hour post meal observation period. The company presented these results at the American Diabetes Association (ADA) 69th Scientific Sessions today in New Orleans.

In addition, Halozyme announced that its first treatment study with three times per day mealtime dosing of Insulin-PH20 in type 1 diabetic patients began in May, ahead of the company’s previous guidance for a fourth quarter 2009 start date... Halozyme Therapeutics' Press release -

NOXXON : Initiation of First Clinical Trial with a Spiegelmer

June 08, 2009 - NOXXON Pharma AG (NOXXON) announced the successful initial dosing of healthy volunteers with Spiegelmer® NOX-E36 in the company’s first-in-human clinical trial. The Phase I program is currently underway in the United Kingdom following review and approval of the Clinical Trial Application by the Medicines and Health product Regulatory Authority (MHRA). The study will evaluate the tolerability, safety and pharmacokinetics in up to 72 individuals following intravenous and subcutaneous administration of anti-inflammatory Spiegelmer® NOX-E36. The results obtained in the Phase I trial will guide the Phase II program to be conducted in patients suffering from nephropathy...
...NOXXON is planning to develop NOX-E36 for the treatment of inflammatory kidney diseases including diabetic nephropathy. Diabetic nephropathy is a growing public health threat due to the high and continually growing incidence of type II diabetes. Approximately thirty percent of patients diagnosed with diabetes develop nephropathy; twenty percent of these patients suffer from end stage renal disease. Diabetic nephropathy is the leading cause for chronic kideny disease and dialysis treatment in the Western world... [pdf] NOXXON's Press Release -

Covidien : Nationwide Our Resolution Movement

Jun. 18, 2009- Initiative Focuses on Role of Gastric Bypass Surgery in Resolving Type 2 Diabetes - As the rate of Type 2 Diabetes soars to epidemic proportions worldwide, Covidien (NYSE: COV), a leading global provider of healthcare products, announced the launch of the Our Resolution movement, a collaboration of healthcare experts, nonprofit organizations, health agencies, patients and national spokespersons who share the goal of resolving Type 2 Diabetes.

According to the World Health Organization, the worldwide incidence of Type 2 Diabetes is projected to grow from 171 million cases currently to 366 million worldwide by 2030. In 2007, the overall economic cost of diabetes in the U.S. was estimated at $174 billion.

The Our Resolution movement specifically focuses on the discovery that gastric bypass surgery resolves Type 2 Diabetes in approximately 77 percent of morbidly obese patients. In fact, for many of these patients, their diabetes or need for medication is resolved within days of surgery. According to the American Society for Metabolic and Bariatric Surgery, approximately 220,000 people in the U.S. had bariatric surgery in 2008. Studies show that those who had surgery dramatically reduced their risk of dying from an obesity-related disease, including the risk of death from diabetes, (down 92 percent), cancer (down 60 percent) and coronary artery disease (down 56 percent)... Covidien's Press Release -